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U.S. FDA Medical Device Prosthesis Valve Requirements

FDA Medical Device Definition: An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

Registrar Corp assists Prosthesis Valve companies with:

  • FDA Prosthesis Valve Establishment Registration
  • FDA Prosthesis Valve Listing
  • FDA Prosthesis Valve Label Requirements and Exceptions
  • FDA Prosthesis Valve Import Information
  • FDA Prosthesis Valve Detentions (Prosthesis Valve Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Prosthesis Valve Manufacturers (Prosthesis Valve Suppliers)
       - Prosthesis Valve Distributors
       - Prosthesis Valve Processors
       - Prosthesis Valve Repackers
       - Prosthesis Valve Relabelers
       - Prosthesis Valve Exporters
       - Prosthesis Valve Importers
For more information about Prosthesis Valve Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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